ASTM D6319-2000a(2005) Standard Specification for Nitrile Examination Gloves for Medical Application《医用腈橡胶检验手套的标准规范》.pdf

1、Designation: D 6319 00a (Reapproved 2005)Standard Specification forNitrile Examination Gloves for Medical Application1This standard is issued under the fixed designation D 6319; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the y

2、ear of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers certain requirements for nitrilerubber gloves used in conducting medical examination

3、s anddiagnostic and therapeutic procedures.1.2 This specification covers nitrile rubber examinationgloves that fit either hand, paired gloves, and gloves by size. Italso provides for packaged sterile or nonsterile or bulk non-sterile nitrile rubber examination gloves.1.3 This specification is simila

4、r to that of SpecificationD 3578 for rubber examination gloves.2. Referenced Documents2.1 ASTM Standards:2D 412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersTensionD 573 Test Method for RubberDeterioration in an AirOvenD 3578 Specification for Rubber Examination GlovesD 3767 Pract

5、ice for RubberMeasurement of DimensionsD 5151 Test Method for Detection of Holes in MedicalGlovesD 6124 Test Method for Residual Powder on MedicalGloves2.2 ISO Standard:ISO 2859 Sampling Procedures and Tables for Inspectionby Attributes32.3 Other Documents:U.S. Pharmacopeia43. Significance and Use3.

6、1 The specification is intended as a referee procedure forevaluating the performance and safety of nitrile rubber exami-nation gloves. It is not intended for testing prior to routine lotrelease. The safe and proper use of nitrile rubber examinationgloves is beyond the scope of this specification.4.

7、Material4.1 Any nitrile rubber polymer compound may be used thatpermits the glove to meet the requirements of this specification.4.2 A lubricant that meets the current requirements of theU.S. Pharmacopeia for absorbable dusting powder may beapplied to the glove. Other lubricants may be used if their

8、safety and efficacy have been previously established.4.3 The inside and outside surface of the nitrile rubberexamination gloves shall be free of talc.5. Sampling5.1 For referee purposes, gloves shall be sampled fromfinished product, after sterilization when labeled sterile, andinspected in accordanc

9、e with ISO 2859. The inspection levelsand acceptable quality levels (AQL) shall conform to thosespecified in Table 1, or as agreed upon between the purchaserand the seller, if the latter is more comprehensive.6. Performance Requirements6.1 Gloves, sampled in accordance with Section 5, shallmeet the

10、following referee performance requirements:6.1.1 Product comply with requirements for sterility whentested in accordance with 7.2 when labeled sterile.6.1.2 Shall comply with freedom from holes when tested inaccordance with 7.3.6.1.3 Have consistent physical dimensions in accordancewith 7.4.6.1.4 Ha

11、ve acceptable physical property characteristics inaccordance with 7.5.6.1.5 Have a powder residue limit of 2.0 mg in accordancewith 7.66.1.6 Have a recommended maximum powder limit of 10mg/dm2in accordance with 7.7.1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand is th

12、e direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved Dec. 1, 2005. Published December 2005. Originallyapproved in 1999. Last previous edition approved in 2000 as D 6319 00ae3.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact

13、 ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute, 25 W. 43rd St., 4thFloor, New York, NY 10036.4U. S. Pharmacopeia, latest edition, Mac

14、k Publishing Co., Easton, PA 19175.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.7. Referee Test Methods7.1 The following tests shall be conducted to ensure therequirements of Section 6, as prescribed in Table 1:7.2 Sterility TestT

15、esting for sterility shall be conducted inaccordance with the latest edition of the U.S. Pharmacopeia.7.3 Freedom from HolesTesting for freedom from holesshall be conducted in accordance with Test Method D 5151.7.4 Physical Dimensions Test:7.4.1 The gloves shall comply with the dimension require-men

16、ts prescribed in Table 2.7.4.2 The length shall be expressed in millimetres as mea-sured from the tip of the middle finger to the outside edge ofthe cuff.7.4.3 The width of the palm shall be expressed in millime-tres as measured at a level between the base of the index fingerand the base of the thum

17、b. Values of width per size other thanlisted shall meet the stated tolerance specified in Table 2.7.4.4 The minimum thickness shall be expressed in milli-metres as specified in Table 2 when using a dial or digitalmicrometer that meets requirements described in Test MethodsD 412 and Practice D 3767,

18、and in the locations indicated inFig. 1. For referee tests, cutting the glove is necessary to obtainsingle-thickness measurements. (See Practice D 3767 for moreinformation.)7.5 Physical Requirements Test:7.5.1 Before and after accelerated aging, the gloves shallconform to the physical requirements s

19、pecified in Table 3.Tests shall be conducted in accordance with Test MethodsD 412.7.5.2 Accelerated AgingThe gloves shall be aged inaccordance with Test Method D 573. Test the gloves inaccordance with the following methods:7.5.2.1 After being subjected to a temperature of 70 6 2Cfor 166 6 2 h, the t

20、ensile strength and ultimate elongation shallnot be less than the values specified in Table 3. This methodshall be the conditions for referee tests.7.5.2.2 After being subjected to a temperature of 100 6 2Cfor 22 6 0.3 h, the tensile strength and ultimate elongationshall not be less than the values

21、specified in Table 3.7.6 Powder Free GlovesDetermine the powder residueusing Test Method D 6124.7.7 Powdered Gloves:7.7.1 Determine the recommended maximum powder limitusing Test Method D 6124 for powdered gloves.7.7.2 Determine the square decimetres for the glove size asin the paragraph on determin

22、ing the square decimetres of glovesize in Specification D 3578.8. Acceptance8.1 Gloves will be considered to meet the referee perfor-mance requirements when test results conform to the require-ments prescribed in Table 1.8.2 Retests or reinspections are permissible under the pro-vision of the U.S. P

23、harmacopeia and ISO 2859.9. Packaging and Package Marking9.1 Sterile Packaging:9.1.1 The unit of packaging shall normally be one glove orone pair of gloves.9.1.2 A glove or pair of gloves, normally, shall be enclosedin an inner wallet or wrapper. The wrapper shall be of sufficientsize when opened to

24、 provide a field for glove-donning pur-poses.9.1.3 The glove or pair of gloves, and accompanyingwrapper if utilized, shall be totally enclosed in an outerpackage that will allow sterilization of the product.9.1.4 The outer package shall have a method of closuresufficient to ensure the sterility of t

25、he product until opened ordamaged.9.1.5 The outer package shall have sufficient strength andintegrity to withstand normal transportation and storage withinthe intermediate or shipping cartons, or both.9.1.6 The method of closure of the outer package shall besuch that prior opening will be detectable

26、 by the user.TABLE 1 Performance RequirementsCharacteristic Related Defects Inspection Level AQLSterility fails sterilityAN/AFreedom from holes holes G-1 2.5Dimensions width, length, and thickness S-2 4.0Physical properties before aging, afteraccelerated agingS-2 4.0Powder-free Residue exceeds maxim

27、um limit N=5 N/APowder Amount exceeds recommendedmaximum limitN=2 N/AASee U.S. Pharmacopeia.TABLE 2 Dimensions and TolerancesNOTESizing that falls within the tolerance overlaps between two sizes may be labeled as a size range including both sizes, for example, small/mediumand medium/large.Designatio

28、nSizeTolerance, mm6612 7712 8812 9Width by size 75 83 89 95 102 108 114 66Width by x-small small Unisize medium large X-large 61070 80 85 95 110 120Length 220 220 230 230 230 230 minThickness, mm:finger 0.05 minpalm 0.05 minD 6319 00a (2005)29.1.7 None of the packaging material shall contain anymate

29、rial likely to impair the quality and use of the gloves.9.1.8 Intermediate cartons and shipping cases shall be ofsufficient strength to maintain the quality and sterility of theproduct during normal transportation and storage.9.2 Nonsterile and Bulk Packaging:9.2.1 The gloves shall be enclosed in an

30、 outer package thathas sufficient strength to withstand normal transportation andstorage within the cartons or shipping cases, or both.9.2.2 None of the packaging material shall contain anymaterial likely to impair the quality and use of the gloves.9.2.3 Cartons and shipping cases shall be of suffic

31、ientstrength to maintain the quality of the product during normaltransportation and storage.9.3 Package Marking:9.3.1 Sterile packages shall bear markings for the contentsto include the glove size, instructions for opening, the legend“sterile,” and a manufacturing lot number.9.3.2 Nonsterile and bul

32、k packages shall bear markings forthe contents to include the glove size and a manufacturing lotnumber.9.3.3 The outermost case shall be labeled with the glove sizeand a manufacturing lot number. Sterile product cases shallalso be marked with the legend “sterile.”9.3.4 All levels of packaging shall

33、conform to all appropri-ate government labeling regulations.10. Keywords10.1 examination gloves; nitrile; rubberFIG. 1 Location of Thickness MeasurementsTABLE 3 Physical RequirementsBefore Aging After Accelerated AgingTensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation14 MPa, m

34、in 500 % min 14 MPa min 400 % minD 6319 00a (2005)3ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent righ

35、ts, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for

36、revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing

37、you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).D 6319 00a (2005)4